MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS REV F TIB.OFFSET CEMENT.T1; KNEE ENDOPROSTHETICS

Model Number	NR071Z
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.Based upon the investigations results, a corrective action/preventive action (capa) was not necessary.
Event or Problem Description
It was reported to aesculap inc.That a columbus rev f tib.Offset cement.T1 (part # nr071z-as) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, during the cementing process of the tibia tray and stem, the cement worked its way into the tibia baseplate.The cement entered the tibia tray at the junction of the inferior side of the tibia tray.The cement obstructed the threaded screw hole for the tibial insert screw.Reportedly, the surgeon spent extra time removing the hardened cement from the small screw hole before the screw was able to be placed.However, the surgeon was able to clear the cement and insert the screw, and then the procedure was able to be continued and successfully completed.The complaint device was not returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The adverse event / malfunction is filed under aic reference (b)(4).

• Brand Name: AS COLUMBUS REV F TIB.OFFSET CEMENT.T1
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12610661
• Report Number: 2916714-2021-00197
• Device Sequence Number: 11096516
• Product Code: JWH
• UDI-Device Identifier: 04046963175948
• UDI-Public: 4046963175948
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2021
• Report Date (Section F): 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2025
• Device Model Number: NR071Z
• Device Catalogue Number: NR071Z
• Device Lot Number: 52629268
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/17/2021
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 10/11/2021